1. Field of the Invention
The present invention generally relates to methods, systems and apparatuses for bony fixation and more particularly to methods, systems and apparatuses adapted for fixing the bones of the spine.
2. Background of the Invention
Fixation or fusion of vertebral columns with bone or material, rods or plates is a common, long practiced surgical method for treating a variety of conditions. Many of the existing procedures involve the use of components that protrude outwardly, which may contact and damage a body part, such as the aorta, the vena cava, the sympathetic nerves, the lungs, the esophagus, the intestine and the ureter. Also, many constructions involve components that may loosen and cause undesirable problems, often necessitating further surgical intervention. Additionally, limiting the success of these procedures are the biomechanical features of the spine itself, whose structure must simultaneously provide support to regions of the body, protect the vertebral nervous system and permit motion in multiple planes.
As indicated above, spinal surgery for spine fusion generally involves using implants and instrumentation to provide support to the affected area of the spine while allowing the bones thereof to fuse. The technology initially evolved using bone chips around and on top of an area of the spine that had been roughened to simulate a fracture in its consistency. The area, having encountered the bone chips, would then proceed to heal like a fracture, incorporating the bone chips. However, surgical procedures dealing with the spine present notable challenges. For example, bioengineers have been required to identify the various elements of the complex motions that the spine performs, and the components of the complex forces it bears. This complexity has made it difficult to achieve adequate stability and effective healing in surgical procedures directed to the spine.
One surgical technique provided by Cloward, involves cutting a dowel type hole with a saw across or through the moveable intervertebral disc and replacing it with a bone graft that was harvested from the hip bone. This procedure limits motion and mobility and results in a fusion of the adjacent vertebral bodies. However, as a result of the complex motions of the spine, it is often difficult to secure the dowel from displacing. Further, it has become apparent over time, however, that this particular technique does not always yield a secure fusion.
Other techniques have been developed that involve the placement of various hardware elements, including rods and hooks, rods and screws and plates and screws. The dowel technique also has advanced over the past five years or so, with dowels being fabricated from cadaver bone or metals such as titanium or stainless steel. These techniques, whether using hardware, dowels or some combination thereof, have a common goal to enhance stability by diminishing movement, thereby resulting in or enhancing the potential of a fusion of adjacent vertebral bones. For example, in one of these other techniques, the disc is removed and adjacent vertebrae are positioned in a stable position by placing a plate against and traversing them, which plate is secured or anchored to each by means of screws.
In another procedure, cages in the form of two parallel circular or rectangular devices are made out of a material such as titanium or stainless steel and these devices are fenestrated. Bone is packed in the center of the devices that will heal to adjacent bone through each fenestration. In this procedure, the disc space is distracted so all ligamentous structures are taut and the bones are held in their normal maximal position of distraction. Because the cages are implanted in spongy bone, they are more likely to collapse the surrounding bone, thus resulting in loss of distraction and subsequently cage dislodgment.
U.S. Pat. No. 5,591,235 reports a certain spinal fixation device and technique for stabilizing vertebrae. In this technique, a hollow screw is inserted into a hole, preferably a hole saw recess, in each adjoining vertebrae. A channel is cut into the vertebrae, which is lined up with corresponding axial slots in the screw. A rod is inserted into the channel and so as to pass through the axial slots in the screw. The rod is secured to each of the screws by means of a locking cap. The rod also is arranged so as to provide a bridge between the hollow screws in the adjoining vertebrae. Certain disadvantages have been surmised using such a device and technique. For example, it has become apparent that the trough in the vertebral bodies destabilizes some of the cortex of the vertebrae body wall, which is the strongest component.
Thus, it would be desirable to provide a new apparatus, system and methods for spinal fixation that enhances healing of the bone while providing structural support to the spine. It would be particularly desirable to provide such an apparatus, system and method that would involve the use of open surgical or minimally invasive surgical techniques as well as a technique in which the implant burrows in the bone spine, traverses across the disk space, and ends in an adjacent or neighboring vertebrae or vertebras, providing limited or no protrusions. It also would be desirable to provide such an apparatus, system and method where the implant is retained within the bone without requiring contour-varying external vertebral wall fixation as compared to conventional devices, as such a device would avoid many of the problems associated with conventional devices such as blood vessel injury, erosion into organs, as well as placement near nerves.
I have now found new methods and apparatus for fixing adjacent vertebrate of a spine. The methods and apparatus of the invention utilize a new implant member, which preferably is arcuate, and avoids the associated problems with prior cage or straight rod and screw systems. It is within the scope of the present invention for the implant member to have any geometric shape or configuration consistent with the intended use including a straight member.
Preferred methods of the invention for stabilizing adjacent vertebrae of the spine, include the steps of providing a positioning apparatus including two guide sleeves, each guide sleeve having a long axis and locating the two guide sleeves with respect to the adjacent vertebrae such that a vertex formed by the long axis of each guide sleeve is located in the intervertebral space for the adjacent vertebrae. The method further includes forming an aperture in each of the adjacent vertebrae using the guide sleeves and inserting an implant into the apertures formed in each of the adjacent vertebrae so that the implant extends between the adjacent vertebrae and through the intervertebral space.
Preferably, the aperture formed in the vertebrae is arcuate and the implant being inserted also is arcuate. The arcuate aperture in each vertebrate can be suitably formed by drilling or other ablation. More particularly, an initial aperture can be drilled in each of the adjacent vertebrae to create intersecting apertures with convergent paths within the intervertebral space; and the initial aperture then enlarged to receive the implant. That enlarging of the initial aperture can be suitably performed by a variety of procedures, e.g. by using a drill bit, a reamer, an awl, impaction drill, shape memory coring device, or curved coring device, or the like.
The step of forming an aperture also can further include inserting a guide member, after drilling of the initial aperture, into one of the guide sleeves, down through the initial aperture in one adjacent vertebrae, through the intervertebral space and into the initial aperture in the other adjacent vertebrae; and advancing an aperture enlarging device over the guide member so as to enlarge the initial aperture. In this case, the aperture enlarging device is suitably a curved reamer or a curved drill bit, and the curved reamer or the curved drill bit is advanced over the guide member so as to form an arcuate aperture in each of the adjacent vertebrae. It also should be appreciated that multiple vertebral holes can be created using the same methods as disclosed herein. In that manner, multiple arcuate implants can be placed, e.g. if greater mechanical stability is considered desirable.
The positioning apparatus can further include a cross member and an intervertebral spacer, preferably where the guide sleeves are pivotally mounted to the cross member and the intervertebral spacer is spaced from the cross member and interconnected thereto at about a mid point between the pivot points for the guide sleeves. In this case, the stabilizing method can further include locating the intervertebral spacer in the intervertebral space between the adjacent vertebrae; and maintaining alignment of the guide sleeves with respect to the adjacent vertebrae so that a consistent angle is maintained between the guide sleeve and the vertebrae during at least a portion of said forming of the aperture. The intervertebral spacer also can be configured so as to provide protection to the spine during the drilling when disposed in the intervertebral space.
In an alternative embodiment, the positioning system being provided includes a cutter bracket system and a curved drilling sub-system affixed thereto. The cutter bracket system includes a pivot arm whose pivot point is disposed between the adjacent vertebrae opposite the intervertebral space. More particularly, the pivot point is at about the midpoint between the adjacent vertebrae. The curved drilling sub-system is affixed to the pivot arm such that as the pivot arm rotates about the pivot point the curved drill sub-system follows an established cutting path. In a more specific embodiment, the drilling sub-system is affixed proximal or at the distal end of the pivot arm. The positioning apparatus according to the alternative embodiment can further include a mechanism that temporarily secures the cutter bracket system to the adjacent vertebra to be fused and which positions and maintains the pivot point at the desired location. Also, the curved drill subsystem can include a curved cannula, a flexible member running through the curved cannula and a cutting burr secured to an end of the flexible member.
As to the step of forming an aperture using a positioning system according to the alternative embodiment, this step includes rotating the pivot arm in one direction about the pivot point so the curved drilling sub-system forms an aperture in one of the adjacent vertebrae and rotating the pivot arm in another direction about the pivot point so as to form an aperture in the other of the adjacent vertebrae. In a more specific embodiment, the step of forming further includes remounting the curved drilling subsystem to the pivot arm before rotating the pivot arm in the another direction so a cutting element of the curved drilling subsystem is aligned for the direction of movement.
As to inserting the implant, the method step includes successively drawing a portion of the implant through the arcuate aperture in one adjacent vertebrae, through the intervertebral space and into the arcuate aperture of the other adjacent vertebrae. In a specific embodiment, the step of inserting includes securing one end of a guide wire to an end of the implant; passing a free end of the guide wire through the arcuate aperture in one of the adjacent vertebrae, through the intravertebral space and through the arcuate aperture in the other adjacent vertebrae; and pulling on the guide wire free end to thereby successively draw the portion of the implant.
In another embodiment, the step of inserting includes inserting a beginning end of the implant into an entrance opening of one of the adjacent vertebrae; applying a force to the portion of the implant extending from the entrance opening so as to drive the implant beginning end though the arcuate aperture in the aperture of said one of the adjacent vertebrae, through the intervertebral space and into the arcuate aperture in the other of the adjacent vertebrae.
The implant being inserted into the final aperture is made from one or more of a metal (e.g., titanium or stainless steel), bone, morphogenic protein (including a combination of bone and bone morphogenic protein), carbon fiber composite, nitinol or biodegradable materials such as polyactic acid or polyglycolic acids and copolymers and other derviatives thereof, or collagen and collagen coated metal or bone. The implant also may comprise an in situ-formed plug where the aperture acts as a mold for an epoxy or other polymer-based system. Also, the implant can be solid or hollow and arranged with or without ingrowth fenestrations and screw holes for post-insertion securement. The implant also can be configured so the implant includes a first and a second section, where a distal end of each of the first and second sections is configured so as to be capable of being secured together. For such an implant, the method further includes the steps of inserting the first section into the aperture in one of the adjacent vertebrae so that the distal end therefore is disposed in the intervertebral space; inserting the implant second section into the aperture in one of the adjacent vertebrae so that the distal end therefore is disposed in the intervertebral space; and securing the distal ends of the first and second sections together. The implant sections being inserted can be arcuate with a radius substantially the same as the arcuate aperture or substantially straight. In particular embodiments, the distal ends of the implant sections are secured to each other by e.g. a nut, bolt, pin, expansion or press-fit device, or interlocking member on the end of each section. Other stabilization methods also can be employed. For instance, a plate can be applied to the vertrebrae surface with attachments at each end of the tunnel traversed by an implant in accordance with the invention.
Another method of the present invention for stabilizing adjacent vertebrae of the spine includes the step of forming a common channel in and between the adjacent vertebrae and inserting a biscuit implant in the common channel so as to bridge between the adjacent vertebrae. In more specific embodiments, the step of forming includes simultaneously cutting a slot, preferably an arcuate slot, in each of the adjacent vertebrae so as to form the common channel and providing a device configured so as to be capable of simultaneously cutting the slot in each of the adjacent vertebrae. Also for said step of inserting, the biscuit implant can be further configured so as to include a spacer element that is received in the intervertebral space between the adjacent vertebrae when the biscuit is disposed in the common channel.
In another alternative aspect of the invention, a diskectomy can be performed and a stabilizing wedge (inner) implant inserted between the vertebrae. The wedge (inner tool) establishes lordosis, provides a construction reference, and carries on it the stabilizing wedge implant. Retracted stop-cut blades on the inner tool are then engaged, cutting into the vertebrae in the vertical plane. A hole saw can be used to create a circular cut in the vertebrae to facilitate insertion of the outer implant. Once the cut is complete, the bone harvested in the tubular cutter can be manipulated into the implant. A circular (outer) implant is then inserted over the inner tool. The outer tool then references the position of the inner tool and guides the implant into place. After the two implants nest together along a key and groove, the outer tool is removed. A fenestrated circular member then replaces the outer cutting tool and the inner tool is rotated about 90 degrees and then removed. Working together, the two rotated implants capture the vertebral body sections, which are now rotated about 90 degrees and through their many holes, provide blood exchange with the adjacent bone to accomplish fusion.
Also featured is a system and apparatus embodying the described methods or techniques for internal fixation of the spine.
Other aspects and embodiments of the invention are discussed below.